Atkins Diet and Prostate Cancer Clinical Trial

Duke University

Status and phase: Terminated; Phase 2

Conditions: Prostate Cancer

Treatments: Behavioral: Atkins Diet

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00932672

Pro00010519

Details and patient eligibility

About

This study will test the hypothesis that a low-carbohydrate Atkins diet will prevent or at least minimize the metabolic consequences of androgen deprivation therapy (ADT).

Full description

Androgen deprivation therapy (ADT) is the standard treatment for advanced prostate cancer. While a very effective anti-cancer treatment, ADT is associated with significant toxicity including but not limited to major metabolic disturbances including impaired glucose tolerance, insulin resistance, and weight gain. We hypothesize that limiting carbohydrates within the diet will prevent or at least minimize these consequences.

Enrollment: 45 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically confirmed adenocarcinoma of the prostate
2. Scheduled to initiate ADT with an anticipated duration of ≥ 6 months
3. Overweight or obese (body mass index ≥ 25 kg/m2)

Exclusion criteria

1. Symptomatic metastatic disease
2. Myocardial infarction within 6 months
3. Treatment with medications known to affect insulin or glucose levels (i.e. insulin, oral hypoglycemics, prednisone, etc.)
4. Patient consuming a low-carbohydrate diet
5. Medical conditions or co-morbidities that preclude participation in the protocol
6. Vegetarians

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Atkins group

Experimental group

Description:

Men assigned to the Atkins diet will be asked to restrict carbohydrate intake to \<20 grams/day. We will use an established clinical program directed by Dr. Eric Westman which implements this diet using a trained clinical nutritionist. No other dietary restrictions will be placed on the subjects. They will measure their urinary ketones at home weekly using urinary ketone strips. Subjects will meet with the nutritionist monthly during the 6 months of the study. Subjects in the Atkins arm will also be asked to walk at a brisk pace for 30 minutes a day, 5 days a week and will be provided a pedometer to measure the number of steps taken per day.

Treatment:

Behavioral: Atkins Diet

Control group

No Intervention group

Description:

Subjects assigned to the control group will be asked to make no changes in their dietary habits. At the completion of the study subjects will meet with the nutritionist and receive standard nutrition AHA recommendations.